- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03412487
Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure
Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure and Its Relation to Thyroid Dysfunction
25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).
*Pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation
For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody
Study Overview
Detailed Description
25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).Pelvic laparoscopy and ovarian biopsy To be examined histologically. All procedures were performed under general anesthesia the utero-ovarian ligament was stabilized with the round biopter introduced through the other. The round metal biopter 5 mm in diameter with an inner protective trocar.
The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness. The round biopter was removed, and a grasper was introduced to recover the excised tissue.
Ovarian biopsy specimens were fixed in 10% formalin and embedded in paraffin forming tissue blocks. Two sections, 4μ thick were cut from each block. One was stained with routine haematoxylin and eosin (H&E) stain while the other was immunostained with anti-Leukocyte Common Antigen (LCA).
For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sahar Elbaradiee, MD
- Email: sbaradie@gmail.com
Study Locations
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-
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Cairo, Egypt, 12151
- Kasr Alainy medical school
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Woman under age of 40y.
- Infertility.
- History of oligomenorrhea or amenorrhea for 1 year or more FSH level >20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure).
- History of thyroid dysfunction, postpartum thyroiditis and or thyroid surgery.
- Symptoms or signs suggestive of thyroid dysfunction or goiter.
- Family history of thyroid dysfunction or goiter.
- Presence of thyroid antibodies or other antibodies.
- Type 1 Diabetes Mellitus.
- Prior irradiation to head and neck
Exclusion Criteria:
Women above 40 yrs.
- Follicle stimulating hormone (FSH) less than 20mIU/mL
- Women using hormonal treatement, exposed to radiation to abdomen or pelvis, chemotherapy, or ovarian surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: premature ovarian failure
women under 40 years old with History of oligomenorrhea or amenorrhea for 1 year or more FSH level >20 IU/L at least 2 occasions 4-6 weeks apart (FSH level 20-40 IU/L indicates ovarian insufficiency, while level above 40 IU/L indicates complete failure).
|
under general anesthesia.
CO2 pneumoperitoneum, the laparoscope inserted through the umbilicus and a thorough evaluation of the abdominal cavity and pelvis was performed.
a grasper was inserted; the utero-ovarian ligament was stabilized with the round biopter will be introduced.
The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles.
After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath.
Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness.
|
Active Comparator: Control group
A group of female patients presented with infertility but with regular menses and normal ovarian function (according to history, general examination, gynecological examination and FSH level).
|
under general anesthesia.
CO2 pneumoperitoneum, the laparoscope inserted through the umbilicus and a thorough evaluation of the abdominal cavity and pelvis was performed.
a grasper was inserted; the utero-ovarian ligament was stabilized with the round biopter will be introduced.
The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles.
After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath.
Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
presence of autoimuune oophoritis
Time Frame: at time of laproscopy procedure
|
Autoimmune oophritis was assessed by quantifying LCA positive cells in ovarian stroma as follows: [Type text] 0= not convincing.
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at time of laproscopy procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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